TBD


Device Classification Name

ophthalmic femtosecond laser

510(k) Number K112098
Device Name TBD
Applicant
LENSAR, INC.
2800 discovery drive
suite 100
orlando, 
FL 
32826

Applicant Contact shirley mcgarvey
Correspondent
LENSAR, INC.
2800 discovery drive
suite 100
orlando, 
FL 
32826

Correspodent Contact shirley mcgarvey
Regulation Number 886.4390
Classification Product Code
OOE  
Subsequent Product Code
HQC  
Date Received 07/22/2011
Decision Date 10/19/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No